5.6 Measure non-physical harms / patient-oriented outcomes pertaining to quality of life
Aside from any possible "direct" biological harm from increased activity/exercise, other "indirect" harms, such as psychological, social, and economic harms (181), are also possible. The magnitude of a harm can be judged by the effect it has on someone's ability to pursue life goals and the duration of this interference (182). A distinction can be made between interfering with minor (e.g. visit a museum, meet friends, vacation, etc.) and major (e.g. attend school, work, have children, etc.) life goals. GET and GA-based CBT programs involve large commitments of time and energy which might interfere with the pursuit of both minor and major life goals by some participants. Given the post-exertional symptoms that are part of ME/CFS (59,183), effects may not just be experienced during the activity sessions and since such programs may not involve an increase in total activity levels, other activities are presumably being substituted for (184). This could put a strain on individuals with ME/CFS in terms of their ability to perform other roles, like employee, student, partner, and/or parent.
Even if eventually an increased total activity level was achieved, there is likely to be a transitory period where a reduced amount of time and energy is available for other aspects of one’s life. This could potentially lead to increased social isolation and, in particular, the break-down of relationships (i.e. have a long-term, rather than just temporary, effect). Outside the ME/CFS arena, it has been recognised that psychosocial treatments can have negative effects on family functioning (185).
In terms of education, a student's academic performance could suffer due to the cognitive problems which can occur post-exercise (171,179): they might underperform or fail exams, or simply fall too far behind and drop out.
In the employment realm, an employee might lose their job because an employer was not satisfied with their performance. In Belgium, an audit of five rehabilitation centres for CFS that involved CBT and GET (66-68) found that the average hours working decreased at conclusion and at follow-up six months later compared to the start. In addition, more people (10%) decreased the number of hours they worked than increased (6%). In fact, when one notes that only 27% were employed before the program, it means 37% (=10/27) of the participants decreased how much they worked (which would have included stopping). A Dutch study of CBT reported better results, with the number of hours worked increasing from a mean (median) of 9.4 (0) hours to 11.4 (0) hours (186). No data was available on the number of people whose hours worked had decreased; however, the mean (median) number of contract hours (cf. hours actually worked) decreased from 16.2 (10) hours to 14.9 (7) hours.
So, even if it were the case that there were no biological harms associated with GET and CBT, individuals with ME/CFS or their physicians could believe that the potential for these secondary or indirect harms might mean that the treatment is not suitable for a specific individual at a particular time.
As is often the case when harms are being recorded, specific checklists may need to be developed that assess some iatrogenic effects – in this case non-biological harms. Spontaneous reporting of harms may not pick up some unintended consequences. Additionally, a greater use could be made of patient-oriented outcome measures. Some might claim that the SF-36 questionnaire (187) would be suitable. However, criticisms have been made that it covers few fields of functional limitation and that several questions cover the same field (two items on “stairs” and three items on “walking”) (188). These five questions make up 50% of the physical functioning subscale which is sometimes used on its own in ME/CFS trials. Given the nature of GE/GA/CBT programs, this may not be a suitable tool to measure functional impairment when assessing such interventions.
ME/CFS studies have found apparent improvements using this subscale without any actual increase in total physical activity (184,189) or a difference with the control group on this instrument was recorded despite no difference in actigraphy (147,190-192). A similar phenomenon has been observed with fatigue scales where an improvement in (self-reported) fatigue scores did not correspond with increased activity (147,184,189,192). Indeed, a recent systematic review of patient-reported outcome measures (PROMs) confirmed that the quality and acceptability of those that have been used in ME/CFS studies as “limited ... [as] [c]lear discrepancies exist between what is measured in research and how patients define their experience of CFS/ME. Future PROM development/evaluation must seek to involve patients more collaboratively to measure outcomes of importance using relevant and credible methods of assessment.”(193)
